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In re Egalet Corporation Securities Litigation

United States District Court, E.D. Pennsylvania

August 2, 2018

IN RE EGALET CORPORATION SECURITIES LITIGATION

          MEMORANDUM RE: DEFENDANTS' MOTION TO DISMISS AND PLAINTIFFS' MOTION TO STRIKE

          BAYLSON, J.

         I. Introduction

         In this securities case, brought pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, a putative class of shareholders possessing shares of Egalet Corporation (“Egalet”) alleges that three of Egalet's executives defrauded the class by failing to disclose that the FDA was likely to grant intranasal labeling exclusivity to a competitor's abuse-deterrent morphine drug. As a result, upon FDA approval of Egalet's own pain management drug, Egalet was not permitted to market its drug as effective at reducing intranasal opioid abuse, and when this news was announced, shares of the stock dropped significantly within a matter of days.

         Presently before the Court are Defendants' Motion to Dismiss, and Plaintiffs' Motion to Strike one of the exhibits that Defendants attached to their Motion to Dismiss.

         For reasons discussed below, Plaintiffs' Motion to Strike is DENIED and Defendants' Motion to Dismiss the Amended Complaint is GRANTED WITH PREJUDICE.

         II. Procedural History

         This case began on January 27, 2017, with the filing of a Class Action Complaint (ECF 1) by Plaintiff George Mineff against Robert S. Radie (“Radie”), Stanley J. Musial (“Musial”), Jeffrey M. Dayno (“Dayno, ” and together with the aforementioned individuals, “Individual Defendants”), and Egalet (together with Individual Defendants, “Defendants”). On February 10, 2017, Plaintiff Steve Klein filed a Class Action Complaint against Defendants in a separately captioned case (17-cv-617, ECF 1), which was designated as related and assigned to the undersigned. On March 28, 2017, two sets of movants filed motions for consolidation of the related cases, appointment of lead plaintiffs, and approval of their respective selections of legal counsel. (ECF 10-11) However, the first of the two motions was withdrawn on April 11, 2017. (ECF 15) Also on April 11, 2017, Defendants filed a response to the remaining motion, expressing their agreement that the related actions should be consolidated. (ECF 16)

         On May 1, 2017, this Court granted the motion of Johseph Spizzirri, Abdul Rahiman, and Kyle Kobold (collectively, “Egalet Investor Group”), thereby consolidating the two related cases under the above caption, appointing Egalet Investor Group as Lead Plaintiff, and approving their selection of counsel. (ECF 17) On May 15, 2017, pursuant to a joint stipulation of the parties, this Court granted leave to Lead Plaintiff to file an amended complaint. (ECF 18) Lead Plaintiff filed its Consolidated Amended Class Action Complaint on July 3, 2017. (ECF 19, “CAC”) The Amended Complaint contains two counts: (1) “Violations of Section 10(b) [15 U.S.C. § 78j(b)] and Rule 10b-5 [17 C.F.R. § 240.10b-5] Promulgated Thereunder Against All Defendants, ” and (2) “Violations of Section 20(a) [15 U.S.C. § 78t(a)] Against the Individual Defendants.” (Id.)

         Presently before the Court are three motions. The first two motions are (1) Defendants' Motion to Dismiss the Amended Complaint, which was filed on September 1, 2017; and (2) Plaintiffs' Motion to Strike Exhibit 1 to Defendants' Motion to Dismiss, or in the Alternative, to Treat Defendants' Motion to Dismiss as a Motion for Summary Judgment, which was filed on October 31, 2017. (ECF 24, “MTD”; ECF 26, “MTS”) The parties submitted Responses and Replies to each motion. (ECF 25, “MTD Response”; ECF 28, “MTS Response”; ECF 29, “MTD Reply”; ECF 31, “MTS Reply”)

         On February 20, 2018, the Court held oral argument on both motions. (ECF 39) During oral argument, Plaintiffs represented to the Court that they would like to avail themselves of the opportunity to file a second amended complaint. Thereafter, on March 6, 2018, Plaintiffs filed the third motion now before the Court, a Motion for Leave to File a Second Amended Complaint (ECF 43), to which they attached a proposed third complaint. Defendants filed a Response (ECF 44) on March 20, 2018, and Plaintiffs filed a Reply on March 27, 2018. (ECF 45) Plaintiff also filed a Motion for Leave to File a Surreply (47), which this Court granted on April 4, 2018. (ECF 48).

         On July 12, 2018, this Court held oral argument on all open motions, specifically addressing with the parties those portions of the proposed Second Amended Complaint which do not appear in the First Amended Complaint. Because Defendants' Motion to Dismiss is addressed to the First Amended Complaint, it is the principal subject of this opinion. The proposed Second Amended Complaint, which almost entirely mirrors the First Amended Complaint, is discussed infra in the context of whether amendment would be futile.

         III. Factual History[1]

A. The Parties

         Plaintiffs are a class of persons who purchased or otherwise acquired shares of Egalet common stock between November 4, 2015, and January 9, 2017, inclusive (the “Class Period”). (CAC ¶ 1)

         Defendant Radie has served as Egalet's CEO, President, and a member of its Board of Directors since March 2012. (Id. ¶ 24)

         Defendant Musial has served as Egalet's Executive Vice President since December 2015, CFO since April 2013, and Principal Financial Officer and Secretary since September 2013. (Id. ¶ 25)

         Defendant Dayno has served as Egalet's Chief Medical Officer since July 2014. (Id. ¶ 26)

         Defendant Egalet is a specialty pharmaceutical company that focuses on developing and commercializing abuse-resistant formulations of opioids and other pain care drugs. (CAC ¶ 33) Egalet's proprietary Guardian Technology employs a novel application of “injection molding” to manufacture “tablets that are hard and difficult to manipulate for misuse and abuse.” (Id. ¶ 34)

         “At the beginning of the Class Period, ” Egalet was developing two late-stage lead product candidates: ARYMO ER™ and Egalet-002. (Id. ¶ 35) Both use Guardian Technology to impede abuse. (Id.) Egalet also acquired two FDA-approved pain care products. (Id. ¶ 36)

         Plaintiffs' Amended Complaint centers on ARYMO ER™ (“ARYMO”). Egalet developed ARYMO as an extended release morphine tablet intended to utilize Guardian Technology to deter abuse of the product by increasing resistance to physical methods of manipulation (e.g., cutting, crushing, grinding), chemical manipulation, and extraction. (Id. ¶ 34)

         B. The 505(b)(2) Pathway to Drug Approval

         In 1984, Congress passed the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984). (See id. ¶ 47) The Hatch-Waxman Amendments require that a drug manufacturer seeking to market a new drug must first obtain approval from the Food and Drug Administration (“FDA”). (Id. ¶ 48) A manufacturer can obtain FDA approval via any of three different application pathways, one of which is known as a Section 505(b)(2) New Drug Application (“NDA”). (Id.)

         An applicant for a 505(b)(2) NDA can receive approval for marketing a new drug even where one or more investigations relied upon for approval “were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.” (Id. ¶ 51) Thus, a 505(b)(2) NDA applicant can rely on previously published reports of studies and the FDA's own findings with respect to drugs that the FDA has previously approved. (Id.) When an applicant relies on clinical studies that were previously submitted to the FDA in support of a different drug, the drug for which the borrowed studies were conducted is referred to as the “Reference Listed Drug” (“RLD”). (Id. ¶ 52) A 505(b)(2) NDA applicant may proffer studies conducted on the RLD to satisfy the applicant's burden of proving a new drug's safety and effectiveness. This generally occurs when the new drug differs only slightly from the RLD, such as a drug product innovation or change in drug strength. (Id. ¶ 54)

         C. Marketing Exclusivity

         The Hatch-Waxman Amendments create certain incentives to encourage innovation of new drug products. (See id. ¶ 55) One of those incentives is “marketing exclusivity, ” which the FDA can grant to new drugs that it approves. (Id. ¶ 54-55) Marketing exclusivity, as its name suggests, provides exclusive marketing rights over a drug. (Id. ¶ 55) It can prevent the issuance of requested labeling language sought by another applicant or prevent the submission or effective approval of other NDAs (such as 505(b)(2) NDAs). (Id.) In other words, when the FDA grants marketing exclusivity to a drug, it confers substantial benefits on the drug. (Id.)

         For a drug to receive exclusivity, it must meet all statutory requirements and receive approval by the FDA. (Id. ¶ 57) There are four categories of exclusivity, one of which is referred to as “Other Exclusivity.” (Id.) One type of “Other Exclusivity” is “new drug product exclusivity.” See 21 C.F.R. § 314.108(b)(4). (Id. ¶ 58) New drug product exclusivity is granted when a 505(b)(2) NDA: (1) contains an active moiety (a sub-division of a molecule) that has previously received FDA approval; (2) includes new clinical investigations (other than bioavailability studies) conducted or sponsored by the applicant that were “essential to the approval of the application”; and (3) is approved by the FDA. (Id. ¶ 58) If these three conditions are met, the FDA will not approve another 505(b)(2) NDA with the same “conditions of approval” for a period of three years from the date of the application's approval. (Id. ¶ 58)

         21 C.F.R. § 314 further defines several of the constituent terms in the second condition above-i.e., “the 505(b)(2) NDA includes new clinical investigations (other than bioavailability studies) conducted or sponsored by the applicant that were essential to the approval of the application.”

         A “new clinical investigation” is:

an investigation in humans the results of which have not been relied on by FDA to demonstrate substantial evidence of effectiveness of a previously approved drug product for any indication or of safety for a new patient population and do not duplicate the results of another investigation that was relied on by the agency to demonstrate the effectiveness or safety in a new patient population of a previously approved drug product.

21 C.F.R. § 314.108(a).

         “Essential to approval” means, “with regard to an investigation, that there are no other data available that could support approval of the application.” Id.

         In 2012, the FDA's Center for Drug Evaluation and Research (“CDER”) created an Exclusivity Board to “provide oversight and recommendations regarding exclusivity determinations made by the CDER, with a primary focus on clarity and consistency of decisions.” (Id. ¶ 68) The Exclusivity Board also “oversees certain exclusivity determinations, including whether and what type of exclusivity should be granted and the proper scope of exclusivity grants.” (Id.)

         If exclusivity is granted to a drug, the FDA will assign it an exclusivity code that details the scope of the exclusivity. (Id. ¶ 70) The code and its description are listed with the drug product's information in the FDA-maintained publication entitled the Approved Drug Products with Therapeutic Equivalence Evaluations. (Id.) Because the cover of the book is orange, it is colloquially referred to as the “Orange Book.” (Id.)

         D. CDER and Abuse-Deterrent Opioids

         In April 2015, CDER published a guide to assist manufacturers wishing to develop opioid drug products with abuse-deterrent properties (the “AD Opioid Guidance”). (Id. ¶ 71) Among other things, the AD Opioid Guidance provides information to drug manufacturers about the FDA's “Physician Labeling Rule.” (Id. ¶ 75) Section 9.2 of the Physician Labeling Rule requires that labeling for abuse-deterrent drug products “state the types of abuse that can occur with the drug and the adverse reactions pertinent to them, and must identity particularly susceptible patient populations.” (Id.) The AD Opioid Guidance supplies additional detail about Section 9.2, stating that

labeling language regarding abuse deterrence should describe the product's specific abuse deterrent properties as well as the specific routes of abuse that the product has been developed to deter. For example, a formulation that limits an abuser's ability to crush a tablet and to extract the opioid can be described as limiting manipulation for the purpose of snorting or injection if the data support such a statement.

(Id. ¶ 77)

         E. ARYMO

         ARYMO, previously discussed in general terms, is an Egalet product for the management of severe, long-term pain. (Id. ¶ 80) It is an abuse-deterrent extended release (“ER”) oral morphine formulation to which Egalet applied its proprietary Guardian Technology “for the expected purpose of it becoming an FDA-approved ER morphine drug product with abuse-deterrent labeling for the intranasal, intravenous, and oral routes of abuse.” (Id. ¶ 79)

         Egalet submitted ARYMO as a 505(b)(2) NDA and selected MS Contin (extended-release morphine tablets) as ARYMO's RLD, thus seeking to establish that its 15mg, 30mg, and 60mg doses were bioequivalent to MS Contin as the same strengths. (Id. ¶ 81) As earlier discussed, an applicant submitting a 505(b)(2) NDA can rely on clinical studies previously submitted to the FDA in support of another drug (the RLD). (Id. ¶ 82) In this case, Egalet submitted its ARYMO application using clinical studies performed on MS Contin. (Id. ¶ 82) It also conducted its own clinical studies in support of ARYMO's approval, including in vitro and human abuse liability studies. (Id. ¶ 83)

         ARYMO's abuse-deterrent properties differentiated it from the “vast majority of the ER morphine products prescribed in the U.S.” (Id. ¶ 89) In fact, ARYMO's prospects for abuse-deterrent labeling for a trifecta of abuse routes-nasal, intravenous, and oral-was “particularly valuable.” (Id. ¶ 90) No. product had received FDA-approved abuse-deterrent labeling for all three routes of abuse. (Id.)

         F. Inspirion and MorphaBond

         Like Egalet, Inspirion is a “pharmaceutical company focused on developing and commercializing products with abuse deterrent features and benefits.” (Id. ¶ 92) It applies its patent-protected SentryBond™ technology to deter and frustrate abuse of its products. (Id. ¶ 93)

         On November 21, 2014, Inspirion submitted a 505(b)(2) NDA for a product called MorphaBond. (Id. ¶ 89) Like ARYMO, MorphaBond is an extended release, orally administered, morphine product. (Id. ¶ 94) Also like ARYMO, MorphaBond is intended for severe, long-term pain management. (Id. ¶ 95) There are other parallels, as well. (See generally id. ¶¶ 92-118)

         Like ARYMO, MorphaBond's application relied on MS Contin as its RLD. (Id. ¶ 97) It conducted in vitro and human abuse liability studies. (Id. ¶ 98-99) Its intranasal abuse potential study was “extremely similar in both [] design and scope” to ARYMO's. (Id. ¶ 101)

         On October 2, 2015, the FDA approved MorphaBond as the first single-entity ER morphine product with labeling describing intranasal abuse-deterrent properties. (Id. ¶ 103) Inspirion issued a press release three days later announcing the results, and MorphaBond's label, including its intranasal abuse-deterrent labeling, was publicly available during October 2015. (Id. ¶ 104-05)

         According to the Amended Complaint, MorphaBond “met all the requirements for receiving exclusivity pursuant to CFR § 314.108(a).” (Id. ¶ 109) The FDA went on to grant MorphaBond a three year period of exclusivity, with its scope defined as “labeling describing the expected reduction of abuse of single-entity extended-release morphine by the intranasal route of administration due to physiochemical properties.”[2] (Id. ¶ 114) The exclusivity period for MorphaBond expires on October 2, 2018. (Id. ¶ 116)

         As a result of MorphaBond's exclusivity, when ARYMO was approved by the FDA, Egalet was not permitted to market ARYMO as effective at reducing intranasal abuse. (Id. ¶ 229) When the public heard this news, shares of the stock dropped significantly within a matter of days. (Id. ¶ 15)

         G. The Alleged False and/or Misleading Statements and Omissions

         Plaintiffs point to twenty (20) “events”-each involving one or more statements (or omissions) during the Class Period--in which Defendants made materially false and/or misleading statements and omissions. Each of the twenty events, as well as the statements or omissions alleged, is described below.[3]

         Event #1: November 4, 2015 Earnings Call

         During the question-and-answer session of Egalet's conference call on November 4, 2015, a stock analyst from Cantor Fitzgerald asked Defendant Radie to comment on the “Defendants' expectations for ARYMO['s] label, ” to which Radie responded that “we would expect that we would have claims for the ability for this product to likely deter [] abuse from an injectability standpoint, from an oral standpoint and from an intranasal standpoint as well.” (Id. ¶ 120)

         Plaintiffs assert that the statements:

(1) “misrepresented and failed to disclose adverse facts pertaining to ARMYO['s] ability to receive the intranasal abuse-deterrent labeling, ” and (2) “were not honestly believed, lacked a reasonable basis, and misrepresented and failed to disclose adverse facts pertaining to the likelihood of ARYMO [] receiving intranasal abuse-deterrent labeling given MorphaBond's exclusivity.”

(Id. ¶ 121)

         Event #2: December 15, 2015 Press Release

         In Egalet's December 15, 2015 press release, it announced that it had filed its 505(b)(2) NDA with the FDA, and that its “submission includes a comprehensive battery of abuse-deterrent studies (Category 1, 2 and 3) which were conducted to support abuse-deterrent label claims for intravenous injection, snorting and oral abuse.” (Id. ¶ 171)

         Plaintiffs assert that the statements were “false and/or misleading [] and/or omitted to disclose that”:

(1) “ARYMO [] could not and would not receive an intranasal abuse-deterrent label upon approval of [its] 505(b)(2) NDA as MorphaBond's marketing exclusivity for intranasal abuse-deterrent labeling precluded any ‘other single-entity extended-release morphine product submitted in [a] 505(b)(2) application [to] be approved for that use, '” and (2) “despite the comprehensive battery of abuse-deterrent studies, ” “the studies would still not allow ARYMO [] to receive FDA approval for the intranasal abuse-deterrent labeling.”

(Id. ¶ 172)

         Event #3: January 11, 2016 Investor Presentation

         On January 11, 2016, Defendant Radie presented a slideshow that Egalet had previously submitted as an attachment to a Form 8-K filed with the SEC. Slides 15 and 17 “touted” the drug's “reductions in oral, intra-nasal, and injection abuse, ” and slide 18 depicted that it was “potential” for ARYMO to receive an intranasal abuse-deterrent label from the FDA. (Id. ¶¶ 129-30)

         Again, according to Plaintiffs, the statements were false, misleading, and/or failed to disclose the existence and effect of MorphaBond's marketing exclusivity on intranasal labeling. (Id. ¶ 131)

         Event #4: March 9, 2016 Earnings Call

         During a March 9, 2016 conference call to discuss Egalet's 2015 Q4 and 2015 FY results, Defendant Dayno stated that the ARYMO NDA submission had included abuse-deterrent studies “to support abuse-deterrent label claims for intravenous injection, snorting and oral misuse and abuse.” (Id. ¶ 134) He also stated that ARYMO is “resistant to particle size reduction, which is the first step in trying to manipulate a product . . . to either snort or inject, ” and he briefly described the positive results from one of Egalet's studies assessing the potential for ARYMO's intranasal abuse. (Id.) Plaintiffs also point to Dayno's statement that the FDA's response to the submission was that “no filing review issues were identified.” (Id.)

         Again, according to Plaintiffs, the statements were false, misleading, and/or failed to disclose the existence and effect of MorphaBond's marketing exclusivity on intranasal labeling.[4](Id. ¶ 135)

         Event #5: 2015 Form 10-K

         Egalet's 2015 Form 10-K, signed and certified by Defendants Radie and Musial, stated that ARYMO's NDA submission included a battery of abuse-deterrent studies “which were conducted to support [abuse-deterrent] label claims for intravenous injection, snorting and oral abuse.” (Id. ¶ 138) It also briefly summarized the positive results from one of Egalet's submitted studies assessing the potential for ARYMO's intranasal abuse. (Id. ¶ 139) The 10-K also discussed the “Risks Related to Our Business and Strategy, ” but was “silent as to any effect that MorphaBond's approval had on the intranasal abuse-deterrent labeling sought for ARYMO.” (Id. ¶ 142) Instead, it only provided one example of how Egalet's business prospects could be affected by an exclusivity period for a competing drug; the example pertained to Egalet-002, not ARYMO:

Furthermore, if the FDA approves a competitor's 505(b)(2) application for a drug candidate before our application for a similar drug candidate, and grants the competitor a period of exclusivity, the FDA may take the position that it cannot approve our NDA for a similar drug candidate. For example, we believe that several competitors are developing extended-release oxycodone products, and if the FDA approves a competitor's 505(b)(2) application for an extended release oxycodone product and grants exclusivity before our NDA for Egalet-002 is filed and approved, we could be subject to a delay that would dramatically reduce our expected market potential for Egalet-002. Additionally, even if our 505(b)(2) application for Egalet-002 is approved first, we may still be subject to competition from other oxycodone products, including approved products or other approved 505(b)(2) NDAs for different conditions of use that would not be restricted by any grant of exclusivity to us.

(Id. ¶ 142)

         Event #6: April 5, 2016 Investor Presentation

         Plaintiffs also point to Egalet's April 5, 2016 Form 8-K, which attached an investor presentation. (Id. ¶ 145) Slides 9 and 11 “touted” the drug's “reductions in oral, intra-nasal, and injection abuse, ” and slide 12 depicted that it was “potential” for ARYMO to receive an intranasal abuse-deterrent label from the FDA. (Id. ¶¶ 146-47)

         Event #7: May 10, 2016 Earnings Call

         During Egalet's May 10, 2016 conference call, Defendant Radie discussed Egalet's preparation for ARMYO's FDA advisory committee meeting, stating “[w]e believe the novelty of our guarding [sic] technology and the strength of our abuse-deterrent data generated from our category one, two and three studies will support a differentiated label for ARYMO.” (Id. ¶ 151) Then, during the question-and-answer session, Radie stated:

We've met all the primary and key secondary endpoints from all of the various category one, two and three abuse-deterrent studies that we conducted. So that gives us a tremendous amount of confidence and the FDA showed some consistency in their review is that they want to see that these products meet the primary endpoint in the various studies that are done and key secondary endpoints as per the guidance that they spent a lot of developing, getting a lot of external expertise to develop those guidance and I think that that's what we're going to see is the sponsors regularly being held to those standards and we believe that ARYMO meet those standards put forth in the guidance.

(Id. ¶ 152)

         Again, according to Plaintiffs, the statements were false, misleading, and/or failed to disclose the existence and effect of MorphaBond's marketing exclusivity on intranasal labeling. (Id. ¶ 153) Moreover, to the extent that any of the statements can be considered statements of opinion, Plaintiffs assert that they “were not honestly believed, lacked a reasonable basis, and misrepresented and failed to disclose adverse facts pertaining to the likelihood of ARYMO [] receiving intranasal abuse-deterrent labeling, ” given MorphaBond's exclusivity. (Id.)

         Event #8: May 11, 2016 Conference Presentation

         During Egalet's presentation at the Bank of America/Merrill Lynch Health Care Conference on May 11, 2016, the company utilized a slideshow they had previously filed as an attachment to a Form 8-K. (Id. ¶ 155) Slides 9 and 10 “touted” the drug's “reductions in oral, intra-nasal, and injection abuse, ” and slide 11 depicted that it was “potential” for ARYMO to receive an intranasal abuse-deterrent label from the FDA. (Id. ¶¶ 156-57)

         Event #9: May 12, 2016 Press Release

         Egalet issued a press release on May 12, 2016 announcing that it had presented data at the American Pain Society's Annual Meeting that demonstrated that ARYMO “significantly lowered intranasal abuse potential as compared to MS Contin (ARYMO['s] RLD).” (Id. ¶ 160) The press release also described the positive results from one of Egalet's studies assessing ARYMO's ability to deter intranasal abuse. (Id. ¶ 161)

         Event #10: June 21, 2016 Form 8-K

         Egalet filed a Form 8-K on June 21, 2016 that contained an investor presentation. (Id. ¶ 164) Slides 27 and 28 “touted” the drug's “reductions in oral, intra-nasal, and injection abuse, ” and slide 12 depicted that it was “potential” for ARYMO to receive an intranasal abuse-deterrent label from the FDA. (Id. ¶¶ 165-66)

         Event #11: June 28, 2016 Press Release

         Egalet issued a press release on June 28, 2016, announcing that the FDA had scheduled a joint meeting for August 4, 2016 with the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (the “Joint Advisory Committee”) to review ARYMO (the “Joint Meeting”). (Id. ¶ 169) The press release indicated that ARYMO's NDA included studies conducted to support abuse-deterrent label claims for intravenous injection, snorting, and oral routes of misuse and abuse. (Id. ¶ 171)

         Event #12: August 4, 2016 Press Release

         On August 4, 2016, the FDA held its Joint Meeting “to discuss whether the clinical data supported approvability and abuse-deterrent labeling for ARYMO.” (Id. ¶ 174) The Joint Advisory Committee tasked with assessing the approvability and abuse-deterrent labeling language for ARYMO described its first task as determining whether there was “sufficient data to support a finding that [ARYMO] has properties that can be expected to deter abuse, commenting on support for abuse-deterrent effects for each of the three possible routes of abuse”: oral, intranasal, and intravenous. (Id. ¶ 177)

         Although the Joint Advisory Committee members “were not asked to evaluate or review whether any FDA-granted exclusivities or patents existed that could affect ARYMO['s] approval or labeling, ” the Joint Advisory Committee voted to recommend to the FDA that the scientific data included with ARYMO's NDA submission supported abuse-deterrent labeling for all three routes of abuse: oral, intranasal, and intravenous. (Id. ¶¶ 178, 183)

         Later on August 4, 2016, Egalet issued a press release announcing the results of the Joint Meeting. (Id. ¶ 182) That press release stated, in relevant part:

[The Joint Advisory Committee] voted 18 to 1 to recommend approval of ARYMO.
[The Joint Advisory Committee] also voted:
• 16 to 3 that if approved, ARYMO [] should be labeled as an abuse-deterrent product by the oral route of abuse;
• 18 to 1 that if approved, ARYMO [] should be labeled as an abuse-deterrent product by the nasal route of abuse; and
• 18 to 1 that if approved, ARYMO [] should be labeled as an abuse-deterrent product by the ...

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